The present invention relates to medical devices for performing surgery and a surgical repair kit containing the same. More particularly, the present invention is directed to a surgical repair kit useful for performing arthroscopic meniscal repairs and other surgical procedures.
Menisci are tough rubbery xe2x80x9cCxe2x80x9d shaped cartilage cushions that are attached by ligaments to the top plateau of the tibia. They prevent the surfaces of the tibia and femur from grinding against each other and act as shock absorbers in the knee.
Menisci are also located in the shoulder, generally known as labrum.
Meniscal tears are a common problem, especially among amateur and professional athletes. The most common meniscus injury occurs in the knee. Each year, tens of thousands of people suffer meniscal tears, particularly in or at the site of one or both knees. If these tears are not repaired, there may be a progressive deterioration of the cartilage, leading to the painful rubbing and wearing of bones which had previously been covered by cartilage. This, in turn, leads to inflammatory synovitis, arthritis and other debilitating ailments. Consequently, at least 30,000 to 40,000 meniscal excisions or repairs are performed to the knee and shoulder each year.
Men and women between the ages of 18 and 45 experience the majority of meniscal tears, usually during athletic activity, such as when twisting, cutting, pivoting, decelerating or when being tackled. When torn, the meniscus may have a longitudinal, horizontal or radial (xe2x80x9cparrot beakxe2x80x9d) tear.
The damaged meniscus may be diagnosed with the assistance or use of magnetic resonance imaging (MRI) and/or an arthroscopic examination. Arthroscopy enables a surgeon to look into the joint using a miniature video camera. In many cases, torn fragments of the meniscus are removed arthroscopically. In other cases, a small tear at the periphery of the meniscus, with a very swollen knee joint, may be treated by draining the joint, temporarily restricting the use of the knee, and slowly having the patient begin rehabilitative exercises.
However, in still other cases, the tears in the meniscus do require surgical repair, normally by sewing the torn sections of the meniscus together. The use of the arthroscope greatly aids in the surgical repair of the meniscus by allowing the surgeon to better visualize the small areas between which the torn meniscus lies. The arthroscope enables the surgeon to visualize the interior of the joint and to perform surgery through small puncture holes without having to open the joint as has been done in the past.
A number of surgical tools have been developed to assist in suturing. In some cases these tools have been developed for use in arthroscopic and/or endoscopic surgery.
In addition to the foregoing, many surgical procedures are currently performed on the shoulder.
More particularly, a group of four muscles around the shoulder joint is called the rotator muscles of the shoulder. The tendonous portion of the muscles that insert into the bony tuberosities of the humeral head is known as the rotator cuff. The rotator cuff is frequently torn at or close to its bony insertion due to trauma or due to degenerative changes associated with aging. Weakness and pain are indications for the surgical repair of rotator cuffs. The surgical procedure consists of re-attachment of the rotator to its bony bed.
Another type of tear in the shoulder that requires attention relates to instability of the shoulder joint after the shoulder has been previously dislocated. The instability is the result of tearing of the joint capsule and its labrum (a fibrocartilaginous structure) from the anterior aspect of the glenoid. This deficiency is commonly known as a Bankart lesion. One method to correct the instability associated with a Bankart lesion is to re-attach the torn capsule and labrum to bone on the anterior aspect of the glenoid.
Both of the above procedures involve re-attaching soft tissues to bone. The arthroscope enables the surgeon to visualize the interior of the joint and to perform surgery through small puncture holes without having to open the joint as has been done in the past. Improvements in instrumentation and in suture anchors have made it possible for surgeons skilled in arthroscopy to perform the above surgical procedures arthroscopically.
The basic steps in arthroscopic rotator cuff repairs and arthroscopic Bankart repairs involve embedding a suture anchor into a bony bed, passing a suture through the soft tissue and tying the soft tissue to the suture anchor, thus coapting the torn tissue to the bony bed. At other times torn or lax tissues are repaired or tightened by passing sutures through two points in the soft tissue, and then tying the sutures together.
U.S. Pat. No. 2,808,055 (Thayer) discloses a surgical stitching instrument which accommodates a bobbin of suture material and includes means to feed the suture material to a needle. A slidable thread-moving member is provided for advancing the suture material through the needle.
U.S. Pat. No. 3,476,114 (Shannon et al.) discloses a ligating implement comprising an elongated instrument through which a ligature passes to form a loop at one end with a disc. The disc provides a means whereby the loop may be drawn tight about a severed vessel or the like.
U.S. Pat. No. 3,476,115 (Graeff et al.) discloses a ligating implement as in Shannon et al., and includes severing means to prevent overstressing of the locking disc during tightening of the noose.
U.S. Pat. No. 4,493,323 (Albright et al.) discloses a suturing device and a method for its use in arthroscopic surgery. The suturing device comprises an elongated tube and plunger which are used to hold and advance a pair of needles united by a length of suture material.
U.S. Pat. No. 4,641,652 (Hutterer et al.) discloses an applicator for tying sewing threads which comprises a helical tubular coil connected to a shaft having an axial passage. A catcher loop is extendable through the shaft to catch a sewing thread inserted manually into the coil passage.
U.S. Pat. No. 4,935,027 (Yoon) discloses surgical instruments and methods for effecting suturing of tissue controlled from a position remote from the suture site. The invention provides for the continuous feeding of suture material through opposed forcep jaw members between which the tissue segments are interposed.
U.S. Pat. No. 5,112,308 (Olsen et al.) discloses a medical device for and a method of endoscopic surgery.
The device includes a dilator having a tapered end and a central passage which accommodates a guidewire for directing the dilator. This device does not include any means whereby the guidewire may be secured to the dilator or otherwise manipulated in conjunction therewith.
U.S. Pat. No. 4,779,616 (Johnson) discloses a method for snagging an end of a surgical suture during arthroscopic surgery, comprising deploying a distal end of a cylindrical cannula adjacent to the end of the suture within the body and passing a resilient loop through the cannula to snag the suture.
U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498 (Caspari et al.) disclose a suturing instrument and method of use in arthroscopic surgery. The suturing instrument includes a hollow needle for penetrating tissue to be sutured within the body while the tissue is clamped between relatively movable jaws and a suture feed mechanism for feeding suture material through the hollow needle. The jaws can be opened and the suturing instrument withdrawn from the body, pulling the free end segment of the suture material with the instrument.
It is an object of the present invention to provide a surgical repair kit. In particular, it is an object of the present invention to provide a surgical repair kit which is particularly suited for the repair of torn menisci.
It is another object of the present invention to provide a suture passer having means for positioning of the suture.
It is another object of the present invention to provide a parallel needle guide to allow for an easier and more successful placement of a second needle in close proximity to a first needle that has been previously inserted in the area of a tissue tear.
Another object of the present invention is to provide a modular suture passer assembly of the sort comprising a handle and a cannula, wherein the handle is adapted to releasably and lockingly hold the cannula for manipulation by a surgeon so that a length of suture may be passed through tissue.
Still another object of the present invention is to provide a surgical kit for use in passing a length of suture through tissue, wherein the kit comprises a handle and various interchangeable cannulas, with each cannula being adapted to be releasably and lockingly held by the handle during a surgical procedure.
Yet another object of the present invention is to provide a surgical cannula having a sharp distal tip which is adapted to pierce tissue.
And another object of the present invention is to provide a surgical cannula having a sharp distal tip which is adapted to pierce tissue while at least one strand of suture extends out of the cannula""s sharp distal tip, wherein the sharp distal tip of the cannula is specially configured so as to minimize the possibility of damaging or severing the suture during the tissue-piercing operation.
Still another object of the present invention is to provide a modular suture passer assembly which is relatively simple to manufacture and relatively easy to use.
Yet another object of the present invention is to provide a new method for passing suture through tissue.
While the present invention is primarily concerned with the repair of torn menisci, the repair kit, the parallel needle guide, and the suture passer may be used in other surgical procedures, e.g., for suturing internal tissue at least partially accessible through a body cavity.
The invention also is suitable for various shoulder surgery repairs such as a Bankart repair and a rotator cuff repair, and other arthroscopic and laparoscopic procedures.
The suture passer of the invention comprises a longitudinally-extending hollow cannula having a central passage slidingly receivable of a surgical suture and a manually graspable handle connected to the hollow cannula for manipulation thereof. The suture passer has a first guide means connected to an upper surface of the handle, proximate to a distal end of the handle, for releasably, guidingly holding the surgical suture, and a second guide means connected to the upper surface of the handle, proximal to the first guide means, for releasably, guidingly holding the surgical suture.
In one embodiment of the invention, the hollow cannula is connected to the upper surface of the handle and the hollow cannula terminates at a rearward opening between the first and second guide means.
In another embodiment of the invention, the hollow cannula is received within a bore formed in the handle, with the bore terminating at an opening in the upper surface of the handle between the first and second guide means.
The guide means may be loops which are either parallel or transverse to the longitudinally-extending hollow cannula. In an alternative embodiment, the second guide means may consist of a plurality of bent fingers lying in parallel planes.
The guide means serve as means about which the suture is passed so it may be manipulated longitudinally with respect to the cannula. The diameter of the central passage of the cannula is such that the tip of a spinal epidural or similar needle into which the suture is directed may fit into the cannula and is large enough to allow the sliding passage of two surgical sutures (i.e., the two limbs of a single surgical suture).
In the method of use, the suture passer is used in surgical manipulations, and in particular meniscal repairs or other arthroscopic procedures, to direct a suture within a joint space with a greater degree of precision than available by current methods.
When the two limbs of a surgical suture are within the cannula, the guide means can function to separate the two limbs. Separation of the two limbs of the surgical suture allows independent manipulation of the suture limbs. Digital manipulation of the surgical suture between the first and second guide means causes longitudinal passage of one limb of the surgical suture within the cannula, i.e., friction between the digit and the said suture will cause the said suture to slide along the top surface of the handle, into or out of the cannula, when manipulated digitally.
In one surgical repair kit formed in accordance with the present invention, the kit comprises a suture passer, as previously described, at least two surgical needles of predetermined length and at least one stylet for each surgical needle. Preferably, the surgical repair kit includes three surgical needles, with one of the surgical needles having a length greater than that of the other needles.
In one preferred embodiment, the suture passer is provided with a metal cannula, and the surgical repair kit includes a cannula bender for bending the metal cannula in a desired manner. The cannula bender comprises a base and a pair of upwardly-stepped, symmetrical bolsters positioned on top of the base, allowing the cannula to be bent to the right or to the left, each step of each bolster having a predetermined radius of curvature wherein the radius of curvature of each step is smaller than the radius of curvature of the step immediately below.
Additionally, in one surgical repair kit formed in accordance with the present invention, the kit may further include a parallel needle guide for guiding the surgical needles for desired placement relative to each other. The parallel needle guide comprises at least three longitudinally-extending, hollow tube-shaped units longitudinally adhered to each other, in a plane, parallel to one another, each of the tube-shaped units slidingly receivable of a surgical needle therethrough.
The present invention also provides methods for the suturing of internal tissue which is at least partially accessible through a body cavity.
A first method comprises the steps of:
(a) providing at least one suture having a first limb and a second limb;
(b) providing a suture passer comprising a longitudinally-extending hollow cannula having a distal opening, a proximal opening and a central passage slidingly receivable of a surgical suture;
(c) introducing the distal end of the cannula into a body cavity at least partially accessing internal tissue to be sutured;
(d) identifying a first insertion site for passing a first limb of a suture through the internal tissue to be sutured;
(e) inserting a first hollow needle through the first insertion site, the hollow needle extending from outside the body through the first insertion site into the body cavity;
(f) identifying a second insertion site for passing a second limb of the suture through the internal tissue to be sutured;
(g) inserting a second hollow needle through the second insertion site, the hollow needle extending from outside the body through the second insertion site into the body cavity;
(h) passing the second limb of the suture through the first hollow needle into the distal opening of the cannula until it exits the proximal opening of the cannula;
(i) feeding the second limb of the suture back into the cannula through the proximal opening;
(j) passing the second limb of the suture through the hollow cannula into the second hollow needle until it exits the needle external of the body;
(k) drawing the suture through the cannula into the body cavity;
(l) removing the first and second needles by drawing them outwardly of the body cavity;
(m) tying the limbs of the suture; and
(n) repeating steps (d)-(m) until a surgically sufficient number of sutures have been tied.
A second method comprises the steps of:
(a) providing at least one suture having a first limb and a second limb;
(b) providing a suture passer comprising a longitudinally-extending hollow cannula having a distal opening, a proximal opening and a central passage slidingly receivable of a surgical suture;
(c) loading the suture passer with a surgical suture such that an end of the first limb of the suture and an end of the second limb of the suture each protrude from the distal end of the cannula;
(d) introducing the distal end of the cannula into a body cavity at least partially accessing internal tissue to be sutured;
(e) identifying a first insertion site for passing the first limb of the suture through the internal tissue to be sutured;
(f) inserting a first hollow needle through the first insertion site, the hollow needle extending from outside the body through the first insertion site into the body cavity;
(g) identifying a second insertion site for passing a second limb of the suture through the internal tissue to be sutured;
(h) inserting a second hollow needle through the second insertion site, the hollow needle extending from outside of the body through the second insertion site into the body cavity;
(i) introducing the end of the first limb of the suture into the first hollow needle until it exits the first hollow needle outside the body;
(j) introducing the end of the second limb of the suture into the second hollow needle until it exits the second hollow needle outside the body;
(k) drawing the suture through the cannula into the body cavity;
(l) removing the first and second hollow needles by drawing them outwardly of the body cavity;
(m) tying the limbs of the suture; and
(n) repeating steps (c)-(m) until a surgically sufficient number of sutures have been tied.
In a further modification of the invention, the suture passer may be formed in a modular fashion so that a variety of different cannulas can be attached to its handle. These cannulas may be blunt or sharply pointed, and they may be straight or curved, as required for a particular surgical procedure. In this form of the invention, the suture passer""s handle includes a female lock portion which is configured to receive and lockingly hold a cannula which is provided with a corresponding male lock portion.
In a preferred form of the modular suture passer, each of the interchangeable cannulas is provided with a radial fin which is attached to the cannula adjacent to the cannula""s proximal end. This fin includes a.main portion and a tab portion. The tab portion of the fin extends proximally from the main portion of the fin. The tab portion of the fin includes an upper tab projection defining an upper, distally-facing tab shoulder and a lower tab projection defining a lower, distally-facing tab shoulder. The tab portion""s upper and lower tab projections are located between the main portion of the fin and the proximal end of the tab portion. The tab portion""s upper and lower tab shoulders are aligned with one another.
The modular handle includes first and second suture guide means generally of the sort disclosed above.
The modular handle also comprises a first bore which extends proximally and axially into the handle from the distal end thereof. The first bore includes a stop at its proximal end. The first bore is sized and positioned so that it can receive the proximal portion of a selected cannula, with the proximal end of the cannula""s central lumen opening onto the upper surface of the handle between the first and second guide means when the cannula""s proximal end is in engagement with the first bore""s stop. A slot extends proximally and axially into the handle from the distal end thereof. The slot communicates with the handle""s first bore and is sized to receive the main portion of the fin of a cannula when that cannula is mounted to the handle.
A cavity is formed in the handle immediately proximal to the slot. This cavity is sized to receive the tab portion of a cannula when that cannula is mounted to the handle. An upper sidewall projection extends inwardly into the cavity from one of the sidewalls of the cavity, and a lower sidewall projection extends inwardly into the cavity from the same sidewall of the cavity. The upper sidewall projection defines an upper, proximally-facing sidewall shoulder, and the lower sidewall projection defines a lower, proximally-facing sidewall shoulder. The upper and lower sidewall shoulders are aligned with one another. The upper and lower sidewall projections are located such that as the tab portion of a given cannula enters the handle""s cavity, the cannula""s upper and lower tab projections will snap over and lockingly engage the handle""s upper and lower sidewall projections when the cannula is fully inserted into the handle""s first bore. In particular, when the assembly is in this locked condition, the cannula""s distally-facing upper tab shoulder will engage the handle""s proximally-facing upper sidewall shoulder, and the cannula""s distally-facing lower tab shoulder will engage the handle""s proximally-facing lower sidewall shoulder.
When a given cannula has been mounted to the handle in the foregoing manner, rotational movement of the cannula relative to the handle is precluded by the engagement of the cannula""s main fin portion with the sidewalls of the handle""s slot. In addition, axial movement of the cannula relative to the handle is precluded (i) in the proximal direction by the engagement of the proximal end of the cannula with the stop located at the proximal end of the handle""s first bore, and (ii) in the distal direction by the engagement of the cannula""s two distally-facing tab shoulders with the handle""s two proximally-facing sidewall shoulders.
The handle of the modular suture passer also includes means for releasing a cannula from its locking engagement with the handle. More particularly, when a given cannula has been mounted to the handle in the foregoing manner, the proximal-most portion of the cannula""s tab portion will extend proximally into a second bore formed in the handle.
The second bore extends axially through the handle, from the proximal end of the handle""s cavity to the proximal end of the handle. A release rod is positioned within the second bore for reciprocal movement therein, between (i) a proximalmost position in which the release rod is withdrawn from engagement with a cannula mounted to the handle, and (ii) a distalmost position in which the release rod is in engagement with a cannula mounted to the handle. Spring means are provided for yieldably biasing the release rod into its proximalmost position. The release rod has a beveled distal end terminating in a drive surface. A cannula is dismounted from the handle by urging the release rod from its proximalmost position to its distalmost position. As the release rod begins to move from its proximalmost position to its distalmost position, the rod""s beveled distal end will first engage the proximal end of the cannula""s tab portion and deflect the tab portion laterally, whereby the cannula""s two distally-facing tab shoulders will be disengaged from the handle""s two proximally-facing sidewall shoulders. Thereafter, as the release rod continues to move from its proximalmost position to its distalmost position, the release rod""s drive surface will engage the proximal end of the cannula""s tab portion, whereby the entire cannula will be driven distally so that the cannula""s two tab projections will clear the handle""s two sidewall projections. This will unlock the cannula from the handle. The cannula may thereafter be manually withdrawn from the handle by pulling the cannula in a distal direction.
In another form of the invention, there is provided a cannula having a proximal end, a distal end, and a passage therethrough, comprising a plurality of hollow cylinders that are interconnected.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle having a proximal end and a distal end; and a cannula mounted on the distal end of the handle; wherein the proximal end of the handle is configured to receive one or more sutures for, passage into the cannula.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle; and a suture guide, having a suture entrance, mounted on said handle; wherein the suture entrance is observable from a transverse projection thereof.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle having a first proximal end; a suture guide, having a second proximal end, mounted on the handle; wherein the second proximal end is distal of the first proximal end.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle; a cannula mounted on the handle; and a proximal suture guide mounted on the handle; the cannula and the proximal suture guide defining a gap therebetween; wherein the gap is optimized to provide maximum suture exposure with limited suture buckling during advancement of the suture.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle having a shape that facilitates orientation thereof.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle; and a cannula mounted on the handle; the handle having a surface for slidingly advancing suture into the cannula; wherein the cannula is aligned with the surface.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a cannula having a distal end; wherein at least a portion of the distal end is configured to drive a suture against tissue without severing the suture.
In another form of the invention, there is provided.an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle including a suture retainer.
In another form of the invention, there is provided an apparatus for receiving and passing one or more sutures, one or more tools, and combinations thereof, comprising a handle; and a cannula, configured to receive the one or more tools, mounted on the handle.
In another form of the invention, there is provided a suture retrieving tool comprising a handle having a distal end and a proximal end; a cannula having a distal end and a proximal end, the proximal end of the cannula being attached to the distal end of the handle, and the cannula having a slot opening on its distal end and extending toward its proximal end; a hook retriever having a distal end and a proximal end, the distal end being configured in the shape of a hook, and the proximal end being attached to the distal end of the handle, the hook retriever having a bend intermediate of its distal and proximal ends; and a sleeve having a distal end and a proximal end, the sleeve being disposed around the hook retriever and within the cannula, the sleeve being slidably attached to the handle such that (1) the sleeve can be positioned in a first retracted position wherein the distal end of the sleeve is disposed proximal to the bend, such that the hook retriever can extend out the slot in the cannula, and (2) the sleeve can be positioned in a second extended position wherein the distal end of the sleeve is disposed distal to the bend, such that the hook retriever will be withdrawn inboard of the slot.